Quick facts
- An artificial eye is a prosthesis that resembles the front of an eye and is worn in the eye socket, usually in front of an orbital implant, for cosmetic purposes.
- In the United States it files under 21 CFR 886.3200, Artificial eye, at Class I, product code HQH (Eye, artificial, non-custom).
- The US exemption from premarket notification is conditional: it holds only where the device uses the same materials, the same chemical composition and the same manufacturing processes as devices already lawfully marketed.
- Canada keeps no named entry. The prosthesis is not implanted and does not enter the body, so Rule 7(1) of Schedule 1 keeps it at Class I.
- The near miss is Rule 2(1), which lifts a device that penetrates a body orifice or contacts the surface of the eye to Class II; the entry's own words, not intended to be implanted, are what keep the worn prosthesis in the non-invasive family.
- Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-14.
An artificial eye is the custom or stock prosthesis that an ocularist or a clinic fits after an eye has been lost or removed: it looks like the front of an eye, it is worn in the socket, and it is made for appearance rather than for vision. The distinction that decides its class is a single phrase in the regulation — the device is not intended to be implanted. This article sets out how the United States names and exempts the prosthesis, how Canada reaches the same class from a rule, where the implant boundary sits, and what a fitting service should keep in the record, with the disposable bed sheets the fitting room uses under the chair.
What is an artificial eye?
It is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant or to an eviscerated eyeball, for cosmetic purposes. A stock eye is selected from a tray of sizes and shapes; a custom eye is moulded to the socket and hand-painted to match the fellow eye. In both cases the prosthesis is worn in the socket and is removed by the patient for cleaning, and in both cases its purpose is appearance.
That last point is the one the rules act on. The prosthesis restores the look of the orbit; it is not a device that restores sight and it is not a device that is placed inside the tissue of the orbit. The implant behind it and the prosthesis in front of it are two separate articles with two separate classes.
Is an artificial eye a Class I device in the United States?
Yes. 21 CFR 886.3200 is titled Artificial eye and the identification reads: \"An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.\" The entry sits at Class I (general controls).
The exemption attached to the entry is worth reading in full, because it is not the plain exemption that most Class I ophthalmic devices carry. The device is exempt from the premarket notification procedures in subpart E of part 807 only if it is made from the same materials, has the same chemical composition and uses the same manufacturing processes as devices that are already lawfully marketed. Change the polymer, or change the process by which the shell is cured, and the conditional exemption does not cover the article. The openFDA device classification API lists product code HQH for the non-custom eye under this regulation number, with a separate code for an artificial iris button.
| Item | Detail |
|---|---|
| US regulation | 21 CFR 886.3200 - Artificial eye |
| US class | Class I (general controls) |
| Product codes | HQH (eye, artificial, non-custom); a separate code covers an artificial iris button |
| Exemption | Conditional: same materials, same chemical composition and same manufacturing processes as a lawfully marketed device |
| Intended use as written | Cosmetic, worn in the socket anterior to an orbital implant or the eviscerated eyeball |
| Implanted? | No; the identification states the device is not intended to be implanted |
How does Canada classify an artificial eye?
Canada keeps no named entry, so the class is derived from Schedule 1 of the Medical Devices Regulations. The prosthesis is not implanted and it does not penetrate a body orifice, so it is not an invasive device and Rule 2(1) — which reaches devices that penetrate a body orifice or that come into contact with the surface of the eye — does not capture it. Rule 7(1) then applies: \"Subject to subrule (2), all other non-invasive devices are classified as Class I.\" The class is Class I, the same answer the United States gives.
The near-miss reading is the one that catches suppliers out, and it is worth stating plainly. A device that is described as an ocular implant — a sphere placed in the orbit, a peg, a tissue expander — is a different article with a different class, because the implant rules act on the fact that the device is placed in the body. A worn prosthesis sits in front of that boundary, and the sentence not intended to be implanted in the identification is what keeps it on the non-invasive side. A fitting service that buys a stock eye and an orbital implant on the same order is therefore buying two lines in two classes, and the labelling is the document that separates them.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 886.3200 - Artificial eye |
| Class | Class I (Rule 7(1), non-invasive) | Class I (general controls) |
| Governing text | Schedule 1, Part 1, Rule 7(1) | 21 CFR 886.3200 |
| Near miss | Rule 2(1) reaches devices that contact the surface of the eye or penetrate a body orifice; a worn prosthesis does neither | Not applicable |
| Exemption basis | Class I obligations, no premarket review of the article | Conditional exemption; materials and processes must match a lawfully marketed device |
Where does the implant boundary sit?
The boundary is the intended use statement, and the two sides of it sit in different regulation numbers. A prosthesis worn in the socket is cosmetic and non-invasive; an implant placed in the orbit or in the eye is invasive, and the rules that act on implanted devices carry a higher class because the consequences of failure are different. A conformity assessment route and a set of records that are adequate for a worn shell are not adequate for a device that is placed inside the tissue.
| Article | Where it sits | Implanted? | Class, Canada | Class, US |
|---|---|---|---|---|
| Artificial eye (worn) | In the socket, in front of the implant | No | I (Rule 7(1)) | I (886.3200, HQH) |
| Orbital implant | Placed in the orbit | Yes | Higher, under the invasive-device rules | II (886.3320 range) |
| Conformer | Worn in the socket after surgery to hold the fornix | No | I (Rule 7(1)) | II (886.3130 range) |
The conformer line in that table is a useful reminder that the same class does not always follow the same word. A conformer and a prosthesis are both worn in the socket and both are removed by the patient, but they were filed on their own entries and on their own intended uses, and a service that buys both should check both lines rather than assume the lower of the two carries over.
What should a fitting service check before ordering?
Three checks. First, confirm the intended use on the labelling of each line, because the prosthesis and any implant it is worn in front of are classified separately and the class follows the label. Second, confirm the material and the process the maker uses, because the US exemption for the worn prosthesis depends on matching a device that is already lawfully marketed. Third, confirm the cleaning and handling instructions the maker states, since the prosthesis is removed, cleaned and reinserted by the patient on a routine the fitting service has to teach and record.
An ocular prosthetics service also restocks the room consumables used at the same fitting chair. Clinics that stock for a whole practice can order through the wholesale programme and request a bulk quote for a standing or annual order; the disposable bed sheets sits in the same catalogue. Reselling? become a distributor.
How does the class affect a fitting routine?
The class sets the market-entry path; the fitting routine is set by the maker's instructions and by the service's own record. A fitting is recorded with the socket condition, the size and fit of the prosthesis, the finish, the cleaning instruction given to the patient and the date of the next review. Where a custom eye is made, the mould and the colour match are recorded with the case so a replacement can be made to the same specification if the prosthesis is lost or damaged.
Because the prosthesis is worn against mucous membrane and handled by the patient, the routine also includes the handling instruction the maker states and the point at which a worn or discoloured shell is replaced. None of that changes with the class; it is the ordinary routine of an ocular prosthetics service, and the record is what shows the prosthesis was fitted and maintained as the maker intended.
Sources
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, medical device databases
- US FDA, overview of device regulation
- Health Canada, medical devices
- Health Canada, establishment licensing
- Standards Council of Canada
- CSA Group
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, application of risk management to medical devices
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- ISO 17664:2017, processing of health care products, information to be provided
- Canadian Association of Optometrists
- College of Optometrists of Ontario, standards of practice
- Canadian Ophthalmological Society
- CCOHS, OSH answers
- Health Canada, medical device licence application guidance
A fitting sheet the patient can take home. Write the prosthesis size, the cleaning step and the review date on one sheet, and the patient leaves with the same instruction the file holds. Open the compliance log centre for the blank printable — no account and no sign-up, and it prints as many copies as the clinic fits in a month.
Dated sheets without the typing. Set the service name and the chair once, and the sterilization log generator produces a dated fitting and handling sheet ready for the quality folder.
Ask a compliance specialist. A classification question usually turns on how the device is used, not only on its name. Ask a compliance specialist — you get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Orbital implants and conformers in Canada vs the US
- Scleral shells in Canada vs the US
- Ptosis crutches in Canada vs the US
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and dental procurement professionals and is not legal advice; the class of a device and the records a practice keeps belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is an artificial eye in the United States?
Class I, under 21 CFR 886.3200, Artificial eye, product code HQH for the non-custom eye.
What class is it in Canada?
Class I, under Rule 7(1) of Schedule 1 of the Medical Devices Regulations, because the worn prosthesis is a non-invasive device.
Why does the phrase not intended to be implanted matter?
Because that phrase is what keeps the article out of the implant rules. A device placed in the orbit is invasive and is classified on that basis; a prosthesis worn in the socket in front of an implant is not.
Is the US exemption automatic?
No. The exemption from premarket notification holds only where the device is made from the same materials, has the same chemical composition and uses the same manufacturing processes as a device that is already lawfully marketed.
What else is an artificial eye called?
It is also written as ocular prosthesis, eye prosthesis, stock eye, custom eye and shell; the US regulation describes the same article as a device resembling the anterior portion of the eye.
Do an artificial eye and an orbital implant share a class?
No. They are separate articles with separate entries. The worn prosthesis is non-invasive; the implant is placed in the body and is classified on that basis.
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